The researchers plan: * To undertake clinical studies of radiotherapy with or without the administration of the chemotherapeutic agent cisplatin, known to be a radiosensitizer; * To perform pre-clinical studies of the radiosensitivity of human fibroblasts and cervical cancer cell lines in culture, with or without the addition of various HIV proteins or protease inhibitors, in order to determine the extent of any cellular radiosensitizing properties of these molecules; * To develop strategies for sensitizing tumour cells to radiation, specifically by down-regulating specific viral proteins that are known to be factors associated with resistance to radiotherapy.
Clinical study addresses the question of whether radiotherapy plus weekly cisplatin offers an advantage over the same radiotherapy given alone in AIDS patients with cervix cancer. External beam radiotherapy is used with 50 Gy in 25 daily fractions (last interim analysis, October 2005) suggested lowering the total dose down to 46 Gy in 23 daily fractions). Brachytherapy component was specified as either 30 Gy of LDR in a single fraction or 3 fractions of 8 Gy using HDR. Cisplatin was administered weekly at a dose of 30 mg/sqm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
322
EBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A
EBRT pelvis 46 Gy 4 field box technique + ICBT LDR 1x30 Gy/A or HDR 3x8 Gy/A + weekly cisplatin 30 mg/m2 during EBRT
Dept. of Atomic Energy, Tata Memorial Centre
Mumbai, India
RECRUITINGJohannesburg Hospital
Johannesburg, South Africa
ACTIVE_NOT_RECRUITINGOcean Road Cancer Institute
Dar es Salaam, Tanzania
RECRUITINGRadiotherapy Centre
Kampala, Uganda
RECRUITINGRadiotherapy Centre
Harare, Zimbabwe
ACTIVE_NOT_RECRUITING3 year recurrence free survival
Time frame: 3 years
Incidence of Grade 3 acute toxicity
Time frame: 3 months
Pelvic control rates
Time frame: 3 years
Tumour response at 3 months.
Time frame: 3 months
Cancer specific survival rates.
Time frame: 3 years
Overall survival rates.
Time frame: 3 years
Acute and late toxicities after the treatment.
Time frame: up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.